ERNST OCCIUS
Malden,MA
Summary
Biotechnology degree candidate with over 12 years’ experience: Fermentation, Cell Culture to Purification. CGMP and extensive experience writing deviation reports and working with QA issues.
Equipped with strong problem-solving abilities, a willingness to learn, and excellent communication skills. Poised to contribute to team success and achieve positive results. Ready to tackle new challenges and advance organizational objectives with dedication and enthusiasm.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Senior Manufacturing
Moderna
01.2021 - 01.2025
- Supervising and developing a team of specialists and associates, ensuring a high-performing and flexible workforce
- Ensuring daily operations run smoothly, including manufacturing readiness, batch closeout, and schedule adherence.
- Applying manufacturing process knowledge and investigational skills to identify and resolve issues.
- Leading and executing projects, working with cross-functional teams, and contributing to technology transfer and capacity expansion.
- Proven expertise / assessing biologics CMC source documentation, writing/reviewing CMC documents
- Driving a culture of continuous improvement in compliance with Moderna's behavioral and ethical standards
- Working on diverse cutting-edge projects, providing input into the product strategy
- Reviewing technical documentation and recommending changes for regulatory compliance, ensuring conformance with existing regulatory approvals
- Maintaining current regulatory knowledge and keeping abreast of regulatory procedures and changes
- Supporting all aspects of assigned ad-hoc taskswith internal teams or affiliates
Senior Manufacturing Associates
Repligen Corporation
01.2010 - 01.2021
- Executing manufacturing procedures that involve bioreactor operation, upstream manufacturing and downstream purification for bio therapeutic molecules from microbial and mammalian sources.
- Executing of validation IQs and OQs, preparation and review of technical reports, writing and reviewing GMP document.
- Executing GMP manufacturing operation and, as required, supporting process Development and technology development.
- Assist or perform routine procedure following written instructions (Sops, batch records, solution documents protocols, etc.)
- Maintain, prepare and clean manufacturing areas, equipment, lab-ware and materials
- Perform autoclave glass washing, SIP.CIP
- Prepare solutions, media and other process related items in support of manufacturing processes
- Operate manual, semi-automated and automated equipment used for the production of biopharmaceuticals
- Assist with validation and Commissioning execution; Write and revise process documentation
- Communicates with Quality Assurance and Materials Management to ensure raw materials are in place and released to prevent manufacturing interruptions
- Support PM schedules, and coordinates with internal and external resources to ensure all equipment is calibrated and maintained as required
- Identifies process improvement opportunities and communicates such opportunities to management
- Reviews batch records for accuracy. Reports deviations to Quality Assurance Participates in development and implementation of CAPAs
- Supervises with leading day-to-day operations; Train new and existing associates.
Purification Associates II
Repligen Corporation
01.2010 - 01.2012
- Large and Pilot scale column chromatography (Affinity, IEX, HIC, and SEC) (Column sizes from 2.5cm to 1m)
- Large/small scale buffer/media preparation
- Sterile filtration, Aseptic liquid fill/finish
- Performed characterization assays such as HPLC, SEC, ELISA, SDS-Page and Western Blot to support cell culture and purification process development activities
- Performed scale up and tech transfer of purification processes(IPA 800 and rSPA) for internal production, and to external partners (Grace and Millipore)
- Interacted and provided support to CMOs and vendors/collaborators/partners during technology transfer activities (A vista for Bioburden and Endotoxin results)
- Experienced with depth filtration, viral filtration and TFF (Product recovery using tangential flow filtration)
- Operate and troubleshoot purification equipment of all scales in the GE AKTA platform including AKTA PURE, AKTA Pilot, AKTA Process, and Buffer Dilution Skids
- Performed in-process concentration analysis by UV using spectrometer
- Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, batch records, etc.)
- Ensure work is carried out in a safe manner, notifying management of safety issues and risks
- Prepared and executed Quality System documents according to established procedures (deviations, change control, CAPA and GMP investigations)
- Initiate deviations or investigations of various complexities and work with cross-functional departments to identify root cause
- Experience with business systems such as ERP and Lean Manufacturing
- Performed sample testing and analysis for in process, release, stability, and non-routine samples
- Played leadership role and trained employees on different purification processes
- Recommend/Implement process changes/improvements of safety/ergonomic improvements.
Lead Chemical Process Technician
E Ink Corporation
01.2006 - 01.2010
- Experience with pigment surface treatment and polymerization and gelatin-based encapsulation
- Ran multi-step chemical processes by both automatic and manual systems including set up, operation and cleaning of process equipment
- Sampled and tested incoming and WIP materials including viscosity, % solids, non-aqueous conductivity, particle size distributions and pH. Participated in test Gage R&R’s
- Process equipment used included mixers, centrifuges, syringe pumps and vacuum ovens
- Made and maintained stock solutions based on production and development schedules
- Prepared weekly WIP and chemical inventory to Manufacturing Manager
- Position required teamwork with other technician and engineers on process improvement and development projects
- Required a flexible hands-on attitude, ability to handle multiple tasks, attention to detail, following written process instructions, filling out run sheets and data entry, good communication skills and training of new operators
- Participated in 5S program and White Belt training
- Attended Spill Training program and participated in company’s safety program
Manufacturing Associate II
Biogen
01.2005 - 01.2006
- Operate complex Biopharmaceutical systems and equipment in strict accordance with current GMP’s, SOP’s and safety guidelines
- Including SIP’s, CIP’s, sterile filtration perform standard Cell Culture and aseptic technique.
- Aseptic hood techniques and sterile vessel operation
- Automated control systems ( Delta V or equivalent )
- Batch record completion, etc.
- Operate manual and automated purification skids; Operate and troubleshoot small equipment
- Validation and Commissioning execution; Write and revise process documentation
- Assist supervisor with leading day to day operations; Train new and existing associates
- Clean and assemble process equipment; Operate autoclaves/sterilize process equipment
- Weighing and mixing of process components; Operate glass and carboy washers
- Prepare media and buffers
- Operate bioreactors
- Bacterial Transformation - transformed E.coli with ampicillin-resistant plasmids and evaluated growth
- Cell Culture Methods - prepared media using sterile technique, counted cells using hemocytometer
Education
Master - Biotechnology Science
Northeastern University
Boston, MA12.2025
Associate in Biotechnology Science - undefined
Bunker Hill Community College
Boston, MA01.2018
Bachelor of Science -
INAGHEI
Haiti05.2006
Bachelor - Accounting
INAGHEI
01.2001
Skills
- Buffer Preparation (by molarity and percent )
- Protein Quantitation - Lowry and BioRad methods
- Column Chromatography - used gel filtration and reversed- phase chromatography
- ELISA - performed simulated HIV ELISA to detect anti-HIV antibodies
- DNA Fingerprinting - digested DNA with restriction enzymes, separated digests by gel electrophoresis
- Bacterial Transformation - transformed Ecoli with ampicillin-resistant plasmids and evaluated growth
- Cell Culture Methods - prepared media using sterile technique, counted cells using hemocytometer
- Knowledge of current Good Manufacturing Practices (cGMPs), SOPs and documentation
- Laboratory Instrumentation: Balance, pipets, micropipettes, spectrophotometer, centrifuge, pH meter (calibration and validation) and microscopes
- Teamwork and collaboration
- Problem-solving
- Dependable and responsible
- Time management
Accomplishments
- Supervised team of 10 staff members.
- Collaborated with team of Eng in the development of Scalling project.
- Resolved product issue through consumer testing.
- Achieved [Result] by completing [Task] with accuracy and efficiency.
Certification
- 5S
- green belt Training -
Languages
French
Native or Bilingual
English
Native or Bilingual
Spanish
Professional Working
Timeline
Senior Manufacturing
Moderna
01.2021 - 01.2025
Senior Manufacturing Associates
Repligen Corporation
01.2010 - 01.2021
Purification Associates II
Repligen Corporation
01.2010 - 01.2012
Lead Chemical Process Technician
E Ink Corporation
01.2006 - 01.2010
Manufacturing Associate II
Biogen
01.2005 - 01.2006
Associate in Biotechnology Science - undefined
Bunker Hill Community College
Master - Biotechnology Science
Northeastern University
Bachelor of Science -
INAGHEI
Bachelor - Accounting
INAGHEI
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